Many drugs administered to patients comprise a compound of medicament components mixed shortly before use. Oftentimes it is necessary to store these substances in separate containers until use. Reconstitution of the compound may require the mixing of a liquid-phase component and a solid-phase component, or the mixing of two liquid-phase components. Commonly, the solid-phase component is in powder form to permit stable storing of a component. The containers used to store these components may be constructed of glass, plastic, or other suitable material.
One way currently used to reconstitute materials requires a first component to be injected with a syringe into a container containing a second component. For example, a syringe having a needle attached thereto is inserted through the rubber membrane top of a container containing a first liquid-phase component. Thereafter, the first liquid-phase component is withdrawn into the syringe barrel. The needle is then removed from the liquid-phase component container. Subsequently, the needle of the syringe is inserted through the rubber membrane top of the second liquid-phase or solid-phase component container and the first liquid-phase component is injected from the syringe barrel into the second container. The second container is shaken to mix the components. Thereafter, a needle attached to a syringe is inserted through the rubber membrane top and the component mixture is drawn into the syringe barrel. The needle is removed from the container and the component mixture may then be administered.
An improvement to this process is the subject of U.S. Pat. No. 6,379,340, entitled “Fluid Control Device”, which utilizes two opposing container receivers to grip and orient the containers. Spikes within the receivers penetrate the rubber membrane top of each container to establish communication with the interior of the containers when mounted on the receivers. Passageways within the spikes and a multi-position valve establish selective communication between the containers and to a syringe thereby allowing the user to reconstitute the drug according to a specific sequence of valve orientations. One shortcoming associated with this device requires the user must manipulate the valve in the correct sequence to reconstitute the drug. In addition, the liquid flowing from the spike and dropping into the solid phase container may cause turbulence and/or frothing on the surface of the fluid. Such frothing may generate a concern to the user that the reconstitution has not occurred correctly.
With respect to these devices, it is desirable to have a system capable of reconstituting a multiple component material using commercially available component storage containers. Additionally, it is desirable to have a reconstitution system wherein the operator may easily control the reconstitution. Furthermore it is desirable to reduce the frothing of the mixture of the solid and liquid phase components during the reconstitution process. It is, thus, also desirable to have a reconstitution device and method that reduces or eliminates the possibility of inadvertent needle sticks.